Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
a CSR shall be submitted when new knowledge arises with regard to the risks of the
substance to human health and/or the environment which would lead to changes in the
SDS;
a CSR shall be submitted because of the change in the classification and labelling of
the substance if this leads to changes in the SDS resulting in a stricter classification.
However, the notifier is strongly encouraged to submit a CSR as defined under REACH in
order i) to confirm that the ESs developed by the regulatory authority are still appropriate and
ii) to describe risk management measures (and subsequent advice to downstream users) at
the earliest opportunity.
The notifier should, where this is required under REACH, submit robust study summaries for
any new study such as the studies requested following decisions made according to Directive
67/548/EEC. For data which was originally submitted as part of the notification and which have
already been evaluated by the Member State Competent Authority, the robust study
summaries need not to be prepared, unless required due to the generation of the CSR.
b) Substances in Biocidal products and in Plant Protection Products
For uses of substances regarded as registered under the Biocides Directive or Plant Protection
Products Directive (see section 2.2.4.1 and 2.2.4.2) the updating requirements do not apply
(Article 16(2)).
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